Brief Title
Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage
Official Title
"A Prospective, Cross-over Randomized Trial to Assess the Efficacy and Safety of Mechanical Percussor "LEGA" Compared With Conventional Chest Physiotherapy in Adults With Chronic Bronchiectasis or Chronic Obstructive Pulmonary Disease (COPD
Brief Summary
A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine
which is supposed to mimic the chest percussion performed by professional physiotherapist to
mobilize sputum through the respiratory passage.
The aim of this study is to compare the effectiveness and safety of this mechanical
percussion device in the treatment of airway clearance with conventional chest physiotherapy
carried out by qualified physiotherapists in patients suffering from bronchiectasis or
Chronic obstructive Pulmonary disease (COPD).
Detailed Description
This study will compare the amount of sputum expectorated during the two procedures and not
intended to look at the clinical improvement of the patient.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.
Secondary Outcome
Change in FEV1 and FVC before and after the two methods of therapy
Condition
Chronic Bronchiectasis
Intervention
Conventional Chest Physiotherapy (CCPT)
Study Arms / Comparison Groups
Conventional Chest PhysioTherapy
Description: Conventional Chest Physiotherapy (CCPT) is delivered by professional physiotherapist for 15 minutes.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
20
Start Date
December 2011
Completion Date
June 2012
Primary Completion Date
June 2012
Eligibility Criteria
Inclusion Criteria:
1. Adult patients > 18 years of age
2. Chronic sputum expectoration-(producing >30ml/day of sputum at baseline)
3. Clinical diagnosis of bronchiectasis or COPD
4. Not carrying out regular chest physiotherapy (for the purposes of this study this will
be defined as less than two occasions per week)
5. Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks
preceding study entry).
6. FEV1 of > 35% of the predicted value in COPD patients
Exclusion Criteria:
1. Primary diagnosis of asthma;
2. Active sarcoidosis
3. Active Pulmonary tuberculosis.
4. History of brittle bones,
5. History of broken ribs in the past one year.
6. History of severe osteoporosis
7. Bleeding from the lungs or haemoptysis
8. Experiencing intense pain in the thoracic region
9. Clinical suspicion of increased intracranial pressure.
10. Have head or neck injuries
11. Have collapsed lungs or a damaged chest wall;
12. Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to
enrollment)
13. Have a pulmonary embolism or lung abscess;
14. Have an active hemorrhage
15. Have injuries to the spine
16. Have open wounds or burns in the thoracic region
17. Have had recent surgery (Within six months prior to enrollment.)
18. Any systemic steroids within 4/52 prior to enrollment
19. Any antibiotics within 4/52 prior to enrollment
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ong L Meng, MBBS, FRCP, ,
Location Countries
Malaysia
Location Countries
Malaysia
Administrative Informations
NCT ID
NCT01480882
Organization ID
CT-11-HPP-001
Secondary IDs
NMRR-11-661-10072
Responsible Party
Principal Investigator
Study Sponsor
Penang Hospital, Malaysia
Study Sponsor
Ong L Meng, MBBS, FRCP, Study Chair, Penang Hospital, Malaysia
Verification Date
December 2012